Consultation Responses

The UKCRC Registered Clinical Trials Units Network has responded to a number of key consultations, below you will find some of our submitted responses:

  • Universities UK Concordat To Support Research Integrity: 2019 consultation on revised Concordat [Issued April 2019] – Network Response
  • National Data Guardian for Health and Social Care: a consultation about priorities [Issued February 2019] – Network Response
  • European Medicines Agency (EMA) consultation on the guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice (EMA/202679/2018) [Issued August 2018] – Network Response
  • NHS England consultation covering changes to simplify arrangements for research in the NHS and associated changes to the terms of the NHS Standard Contract [Issued February 2018] – Network Response
  • European Medicines Agency (EMA) consultation on the guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol’ (EMA/430909/2016) [Issued August 2017] – Network Response
  • European Medicines Agency (EMA) consultation on the guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials’ (EMA/15975/2016) [Issued July 2017] – Network Response
  • ICH E17 Draft Guidelines on “Multi-Regional Clinical Trials”. [Issued December 2016] – Network Response
  • Department of Health Consultation: National Data Guardian for Health and Care’s Review of Data Security, Consent and Opt-Outs. [Issued September 2016] – Network Response
  • Position of research and patient organisations: Implementing the General Data Protection Regulation [2016/679] to maintain a competitive environment for research in Europe. [Issued September 2016] – Joint statement
  • HRA’s consultation: Network response to the UK Health Policy Framework – Network Response
  • HRA’s consultation: Network response to the UK Policy Framework for Health and Social Care Research – Network Response
  • HRA’s consultation on Transparency – Registration and Reporting (Archive) – Network Response
  • SIOP-E Joint Statement on Low Intervention Trials related to the Clinical Trials Regulations – Joint Response
  • NIHR CLRN Clinical Themes consultation – Network Response
  • NHS EU Office consultation on new EU Clinical Trials Regulations:
  1. Network Response to EU Regulations proposed Amendments
  2. Registered CTUs’ Response to Clinical Trials Regulation
  3. Comments on Rapporteur and NHS reports on EUCTR proposal
  • MHRA Public Consultation (MLX 377): Fees legislation for 2013:
  1. Response from the Network
  2. Response from the MHRA
  • EU DATA Protection Regulations – Position Statement – Joint Response
  • Health Research Authority Research Sponsor Responsibilities Consultation – Network Response
  • Network response to  the proposals for the content of the summary of the results of clinical trials (Annex IIIa) and position statement on Transparency – click here.
  • To view our strategy within UKCRC, please click here.

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